Safety and Efficacy Study of Brimonidine in Patients With... | NCT00652483

Studies
Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

NCT00652483

Sponsor

Allergan

Status

Completed

Last Update Posted

Apr 3, 2008Estimated

Enrollment

433Actual

Phase

Phase 3

Conditions

Glaucoma
Ocular Hypertension

Interventions

Brimonidine ophthalmic solution 0.1%
Brimonidine ophthalmic solution 0.2%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2003Actual

Completion Date

Sep 2004Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2008

Last Update Posted Date

Apr 3, 2008Estimated

Description Module

Brief Summary

This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

433Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Brimonidine ophthalmic solution 0.1%	Drug: Brimonidine ophthalmic solution 0.1%
2	Active Comparator	Brimonidine ophthalmic solution 0.2%	Drug: Brimonidine ophthalmic solution 0.2%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brimonidine ophthalmic solution 0.1%	Drug	1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)	1

Measure	Description	Time Frame
Intraocular pressure (IOP)		Week 2 - Month 3

Measure	Description	Time Frame
IOP		Month 6 - Month 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

Uncontrolled systemic disease
Known allergy or sensitivity to brimonidine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Allergan	Study Director

Label	URL
Link to Clinical Trial Results	View source

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068438	Brimonidine Tartrate

Ancestor Terms

ID	Term
D011810	Quinoxalines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided